Non Invasive Characterization of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography (PED_MSOT_IBD)

April 12, 2023 updated by: University of Erlangen-Nürnberg Medical School
Monocentric, prospective observational study to assess bowel inflammation in children with chronic inflammatory bowel disease (IBD) using multispectral optoacoustic tomography (MSOT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inflammatory bowel diseases (IBD) play a major role in child and adolescent medicine. 25 % of patients with IBD are younger than 18 years of age at diagnosis and 25 % of those are even younger than 10 years of age at disease onset. The incidence of IBD in children and adolescents is 5-11/100 000 in Germany. IBD comprises mainly two entities, namely Crohn's disease (CD) and ulcerative colitis (UC). Patients with CD develop chronic and intermittent transmural inflammation of the gastrointestinal tract, which manifests with symptoms like diarrhea, hematochezia, abdominal pain, fatigue and malnutrition. This often results in weight loss and an increased risk of numerous complications such as the development of fistulas, perforations and intestinal strictures. In addition, growth disturbances and delayed onset of puberty are more frequent. Overall, the course of the disease can only be compared between children and adults to a very limited extent, as the disease often progresses more rapidly and severely in children. Accordingly, the procedure and recommendations for children with CD differ from those of adults. In addition to clinical scores, laboratory chemical parameters (blood count, CrP, calprotectin) and imaging diagnostics (endoscopy, ultrasound, MRT) are available to assess disease activity. However, the latter are only of limited use for routine monitoring due to their invasiveness, the need for sedation and the use of contrast agents. Multispectral Optoacoustic Tomograph (MSOT) on the other hand allows, comparable to sonography, a non-invasive, quantitative imaging of the composition of target tissues in children without sedation. Previous studies have shown that the quantitative determination of hemoglobin provides information on blood flow and inflammatory activity in the bowel of adult patients with Crohn's disease. In this pilot study, the intestinal wall of children will be characterized by MSOT to differentiate between CD, UC, and unclassified inflammatory bowel disease (U-IBD) and to quantify changes and correlate them with routine parameters. This could lead to a new possibility of non-invasive evaluation of disease forms and activity comparable to previous findings in adult patients with CD.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • University Hospital Erlangen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from the Department of Pediatric and Adolescent Medicine, University Hospital Erlangen

Description

Inclusion Criteria:

  1. CD patients

    • Diagnosis CD or suspected CD at initial diagnosis
    • Indication for endoscopy and sampling (biopsy)

  2. UC patients

    • Diagnosis UC or suspected UC at initial diagnosis
    • Indication for endoscopy and sampling (biopsy)

  3. U-IBD patients

    • Diagnosis U-IBD or suspected IBD at initial diagnosis
    • Indication for endoscopy and sampling (biopsy)

Exclusion Criteria:

  • Pregnancy
  • Nursing mothers
  • Unstable patients: Need for continuous cardiopulmonary monitoring (ECG and pulse oximetry)
  • Tattoo in the field of investigation
  • Subcutaneous fat tissue over 3 cm
  • Lack of written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Crohn's disease
Patients diagnosed or with suspected Crohn's disease.
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).
Patients with Ulcerative colitis
Patients diagnosed or with suspected Ulcerative colitis
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).
Patients with unclassified inflammatory bowel disease (U-IBD)
Patients diagnosed or with suspected unclassified inflammatory bowel disease (U-IBD)
Device: Multispectral Optoacoustic Tomography (MSOT)
Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative amount of oxygenated/deoxygenated hemoglobin in a.u.
Time Frame: Single time point (1 day)
Oxygenated/deoxygenated hemoglobin signals in the intestinal/bowel wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)
Single time point (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative amount of fibrosis/collagen signal in a.u.
Time Frame: Single time point (1 day)
fibrosis/collagen signals in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)
Single time point (1 day)
Quantitative amount of single wavelength signal in a.u.
Time Frame: Single time point (1 day)
single wavelength signals in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)
Single time point (1 day)
Optoacoustic spectrum in a.u.
Time Frame: Single time point (1 day)
Optoacoustic spectrum in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)
Single time point (1 day)
Endoscopic extent of inflammation
Time Frame: Single time point (1 day), +/- 7 days from MSOT Imaging
Assessment of inflammation in endoscopies within different entities of IBD (CD vs. UC vs. U-IBD)
Single time point (1 day), +/- 7 days from MSOT Imaging
Histological extent of inflammation and fibrosis
Time Frame: Single time point (1 day), +/- 7 days from MSOT Imaging
Assessment of inflammation and fibrosis in histological samples from biopsies within different entities of IBD (CD vs. UC vs. U-IBD)
Single time point (1 day), +/- 7 days from MSOT Imaging
Clinical evaluation
Time Frame: Single time point (1 day)
Assessement of clinical disease status by PCDAI or PUCAI according to the CED within different entities of IBD (CD vs. UC vs. U-IBD)
Single time point (1 day)
Ultrasound
Time Frame: Single time point (1 day), +/- 1 day from MSOT Imaging
Assessment of disease status by ultrasound within different entities of IBD (CD vs. UC vs. U-IBD)
Single time point (1 day), +/- 1 day from MSOT Imaging
Laboratory parameters (blood - c-reaktive protein (CrP))
Time Frame: Single time point (1 day), +/- 7 day from MSOT Imaging
Assessment of disease status by laboratory parameters (CrP) within different entities of IBD (CD vs. UC vs. U-IBD)
Single time point (1 day), +/- 7 day from MSOT Imaging
Laboratory parameters (stool - Calprotectin)
Time Frame: Single time point (1 day), +/- 14 day from MSOT Imaging
Assessment of disease status by laboratory parameters (Calprotectin) within different entities of IBD (CD vs. UC vs. U-IBD)
Single time point (1 day), +/- 14 day from MSOT Imaging
MRI
Time Frame: Single time point (1 day), +/- 14 day from MSOT Imaging
Assessment of disease status by MRI (if applicable) within different entities of IBD (CD vs. UC vs. U-IBD)
Single time point (1 day), +/- 14 day from MSOT Imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 351_20B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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